Overview

Sustainable Growth of
STgen Bio

+

Well trained
manpower

+

Liters of cell
culture capacity a)

+

Clinical projects
(KR, JP, EU, US) b)

+

Commercial products
(KR, JP) c)

  • a) Plan to expand facility to 9,000L (2023 Q3)
  • b) Biosimilar: 12; New Biologics: 2 (DS: 6, DP: 8)
  • c) Biosimilar: 3; New Biologics: 1 (DS: 1, DP: 3)

    • Regulatory Approvals

  • Regulatory compliance track records with approval by health authorities including Japan PMDA, Turkey MoH, and Korea MFDS
  • EU QP audits for investigational medicinal products
  • Pre-approval inspection by FDA and EMA (planned for 2023)